Disinfecting caps having an extendable feature

ABSTRACT

Some assemblies can include a male cap and a female cap, each of which can be used to cover separated medical connectors. In certain arrangements, a male cap can include a movable carriage that transitions from a retracted position when an assembly with which the male cap is associated is in a closed state to an extended position when the assembly is in an open state.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 12/956,704, filed Nov. 30, 2010, which claims thebenefit of U.S. Provisional Patent Application No. 61/265,207, filedNov. 30, 2009. U.S. patent application Ser. No. 12/956,704 is also acontinuation-in-part of U.S. patent application Ser. No. 12/917,336,filed Nov. 1, 2010, which is a continuation-in-part of U.S. patentapplication Ser. No. 12/610,141, filed Oct. 30, 2009 which issued asU.S. Pat. No. 8,172,825 on May 8, 2012. The entire contents of each ofthese applications are incorporated by reference herein.

BACKGROUND

1. Technical Field

The present disclosure generally relates to caps for medical connectorsand more specifically relates to caps that can be used to protect thecleanliness of unconnected medical connectors, such as connectors thatmay be used for fluid flow or for fluid delivery systems. Someembodiments are directed to caps for medical connectors that includeelongated male portions.

2. Related Art

Bloodstream infections, such as may be caused by microorganisms thatenter patients via intravascular catheters, are a significant cause ofillness and excess medical costs. A substantial number of suchinfections occur in U.S. intensive care units annually. Additionally, asignificant fraction of these infections result in death.

Guidelines from the Centers for Disease Control and Prevention describevarious ways to limit bloodstream infections in hospital, outpatient,and home care settings. The guidelines address issues such as handhygiene, catheter site care, and admixture preparation. However, despitethese guidelines, such infections continue to plague healthcare systemsat relatively unchanged rates.

Impregnating catheters with various antimicrobial agents is one approachfor reducing these infections. Impregnated catheters, however, provideless than satisfactory results. Additionally, some microbes havedeveloped resistance to the various antimicrobial agents used in thecatheters. Other systems and approaches have also been developed, butthese likewise suffer from a variety of limitations and drawbacks.

BRIEF DESCRIPTION OF THE DRAWINGS

The written disclosure herein describes illustrative embodiments thatare non-limiting and non-exhaustive. Reference is made to certain ofsuch illustrative embodiments that are depicted in the figures, inwhich:

FIG. 1 is a perspective view of an embodiment of an assembly thatincludes an embodiment of a male cap and an embodiment of a female capthat are coupled with each other in a closed or pre-use configuration;

FIG. 2 is a perspective view of the system of FIG. 1 in an openconfiguration in which the male and female caps are separated from eachother;

FIG. 3 is an exploded perspective view of the system of FIG. 1;

FIG. 4A is a top plan view of an embodiment of a housing portion of afemale cap that is compatible with the assembly of FIG. 1;

FIG. 4B is a side elevation view of the housing portion of the femalecap of FIG. 4A;

FIG. 4C is a front elevation view of the housing portion of the femalecap of FIG. 4A;

FIG. 5A is a top plan view of an embodiment of a housing portion of amale cap that is compatible with the assembly of FIG. 1;

FIG. 5B is a side elevation view of the housing portion of the male capof FIG. 5A;

FIG. 5C is a cutaway perspective view of the housing portion of the malecap of FIG. 5A;

FIG. 6 is a cutaway perspective view of the housing portion of the malecap, as shown in FIG. 5C, with an embodiment of a biasing elementdisposed therein;

FIG. 7 is a cutaway perspective view of the housing portion of the malecap, as shown in FIG. 5C, with both an embodiment of a biasing elementand an embodiment of a carriage disposed therein;

FIG. 8 is a rear perspective view of the carriage that is also shown inFIG. 7;

FIG. 9 is a cross-sectional view of the assembly of FIG. 1 in thepre-use state;

FIG. 10A is a top plan view of the assembly of FIG. 1 in the pre-usestate with an arrow indicating rotation of the female cap relative tothe male cap to assist in transitioning the assembly to the open state;

FIG. 10B is another top plan view of the assembly of FIG. 1 showing thefemale cap having been rotated relative to the male cap so as to assistin translating the female cap away from the male cap;

FIGS. 11A-11D are cross-sectional views that depict various stages of anillustrative method for coupling a medical connector with the male capof FIG. 1;

FIG. 12 is a cross-sectional view of the female cap of FIG. 1 coupledwith an embodiment of a needleless injection site;

FIG. 13 is a cross-sectional view of the female cap of FIG. 1 coupledwith another embodiment of a needleless injection site;

FIG. 14 is a cross-sectional view of the female cap of FIG. 1 coupledwith another embodiment of a needleless injection site;

FIG. 15 is a cross-sectional view of another embodiment of an assemblythat includes an embodiment of a male cap and an embodiment of a femalecap that are coupled with each other in a closed or pre-useconfiguration;

FIG. 16 is an expanded view of the cross-sectional view shown in FIG.15;

FIG. 17 is a cutaway perspective view of an embodiment of a housingportion of another embodiment of a male cap;

FIG. 18 is a cross-sectional view of another embodiment of an assemblythat includes an embodiment of a male cap coupled with an embodiment ofa female cap;

FIG. 19 is a cross-sectional view of another embodiment of an assemblythat includes an embodiment of a male cap coupled with an embodiment ofa female cap;

FIG. 20 is a side elevation view of another embodiment of a male cap;and

FIG. 21 is a perspective view of a fluid line that includes a coupledset of connectors that are amenable to being coupled with male andfemale caps, respectively.

DETAILED DESCRIPTION

Disclosed herein are caps that can be used to protect and/or disinfectmedical connectors. Systems and methods related to such caps are alsodisclosed. The caps, systems, and methods can reduce the threat ofmicroorganisms entering the bloodstream of a patient via fluid flow orfluid delivery systems, such as, for example, needleless injection sitesand/or fluid transfer devices having an elongated male portion or maleprotrusion, such as, for example, a male luer. In some embodiments, acap is configured to couple with and disinfect a medical connectorhaving a male protrusion. In further embodiments, the cap can include anantiseptic, and can be configured to create a seal with the maleprotrusion so as prevent antiseptic from entering a lumen of the maleprotrusion. In some embodiments, the antiseptic may be contained withina pad prior to the coupling of the cap to the medical connector, and theact of coupling the cap to the medical connector can force at least aportion of the antiseptic from the pad and into contact with the maleprotrusion. In still further embodiments, the male cap can be coupledwith a female cap to form an assembly. The male cap can include atranslatable portion that is retained in a retracted position when theassembly is in a pre-use state. Separation of the male and female capscan result in translation of the translatable portion to an extendedposition that is more readily accessible by a medical connector.

By way of background, FIG. 21 illustrates an example of medicalconnectors 300, 360 for which caps disclosed herein may be used. Anysuitable variety of medical connectors 300, 360 is possible, such as,for example, luer lock connectors. The connectors 300, 360 areassociated with a fluid pathway 1200, such as a fluid line 1205 of anysuitable variety, which may be coupled with an IV bag 1210 or othersuitable fluid delivery system. Commonly, the fluid pathway 1200 can beused to intermittently administer medications to a patient P.

In the illustrated embodiment, the connector 360 of the fluid pathway1200, which communicates fluids with a patient's blood stream, may beselectively disconnected from the connector 300. One or more of theconnectors 300, 360 may be connected to other connectors (not shown),such as a connector associated with a central line. The medicalconnectors 300, 360 may be connected and disconnected at various times,and may remain disconnected for several minutes or hours. Medicalconnector caps disclosed herein can be used to cover and protect thevarious medical connectors 300, 360 while the connectors are separatedfrom one another.

Upon separation of the medical connectors 300, 360 from each other, eachseparated connector can benefit from being covered by a cap. Therefore,in some cases, it can be advantageous to have a single connector set orassembly that includes both a male cap and a female cap that can be usedto provide protection for both ends of a separated connection. In otheror further embodiments, a cap can include an antiseptic for disinfectinga medical connector. In some cases, it can be advantageous for the capto form a seal with a portion of the medical connector to therebyprevent the antiseptic from exiting the cap into the fluid pathway. Insome embodiments, a male cap includes a translatable portion that isretained in a retracted position when the cap assembly is in a pre-usestate. Separation of the male and female caps can result in translationof the translatable portion to an extended position that is more readilyaccessible by a medical connector.

FIGS. 1-3 illustrate an embodiment of a set or assembly 100 thatincludes an embodiment of a female cap 102 and an embodiment of a malecap 104, each of which can be used to cover a separated connector 360,300, respectively. The assembly 100 can be provided in a pre-use,assembled, or closed state in which the female and male caps 102, 104are coupled with each other, as shown in FIG. 1. As further discussedbelow, when the caps 102, 104 are coupled with each other, they may forma fluid-tight seal, which can prevent antiseptic from evaporating froman interior of the assembly 100 to an exterior thereof. In particular,the female and male caps 102, 104 can be coupled with each other via asealing mechanism 189. In the illustrated embodiment, the sealingmechanism 189 comprises a sealing sleeve 191, which is fixedly connectedto (e.g., integrally formed with) the male cap 104. The terms “coupled”and variants thereof are used in their ordinary sense and includearrangements such as that illustrated in FIG. 1, in which the caps 102,104 directly engage one another when the assembly 100 is in theassembled or pre-use state.

As shown in FIG. 2, the female and male caps 102, 104 can be separatedfrom each other. It may be said that the assembly 100 is in an open oroperational state when it is in such an arrangement. In the illustratedembodiment, all components of the assembly 100 are contained in orotherwise embodied by one of the female and male caps 102, 104.Accordingly, in some embodiments, the assembly 100 can be devoid ofpieces or parts that are readily separable from either of the female andmale caps 102, 104 during or after a transition of the assembly 100 fromthe closed to the open state. Accordingly, the female and male caps 102,104 each can comprise separate, self-contained, or individual assembliesthat may be directly joined to each other, thereby resulting in thecomposite assembly 100 it its closed state (shown in FIG. 1), and thatmay be separated from each other, thereby resulting in the disassembledassembly 100 in its open state (shown in FIG. 2). A lack of separate,additional parts when the female and male caps 102, 104 are disconnectedfrom each other can have a variety of advantages. For example, sucharrangements can, among other things, provide for a less cluttered workspace or environment when one or more of the caps 102, 104 are in use.

As shown in FIG. 2, and as discussed further below, in certainembodiments, the male cap 104 can include an outer housing 150, whichcan receive a translating or telescoping member, shuttle, or carriage200. The carriage 200 can be configured to transition between aretracted (e.g., distal) position and an extended (e.g., proximal)position. In FIG. 2, the carriage 200 is in the extended position,whereas it is in the retracted position in FIG. 9, as discussed furtherbelow. The male cap 104 can include a biasing member 202, which can beconfigured to urge or bias the carriage 104 proximally toward theextended position.

The terms “proximal” and “distal,” when used herein relative to a cap,or components thereof, are used relative to the coupling of the cap witha medical device, such that the medical device is inserted into aproximal end of the cap, or component thereof and advanced toward adistal end of the cap or component. Accordingly, in the illustratedembodiment, the proximal ends of the caps 102, 104 are directed towardeach other and the distal ends of the caps 102, 104 are directed awayfrom each other when the assembly 100 is in the pre-use configuration(see FIG. 1).

FIG. 3 is an exploded view of the assembly 100. The female cap 102 caninclude a housing 110 into which an antiseptic reservoir or pad 132 isreceived. As previously mentioned, the male cap 104 can include acarriage 200, which can be configured to receive a resilient support177, an antiseptic reservoir or pad 170, and a sealing member 190. Asfurther discussed below, the resilient support 177 and the pad 170 maybe considered as a multi-part biasing member 176 that is configured tourge the sealing member 190 toward a proximal end of the carriage 200.

As previously mentioned, the housing 150 of the cap 104 can beconfigured to receive the biasing member 202 and the carriage 200. Inthe illustrated embodiment, the carriage 200 comprises a movable,translatable, or inner housing 210, and the biasing member 202 comprisesa coil spring 212. As further discussed below, the coil spring 212 canbe configured to urge the inner housing 210 in the proximal direction,or toward a proximal end of the shell or outer housing 150.

With reference to FIGS. 4A-4C and 9, the housing 110 of the female cap102 can extend between a closed distal end and an open proximal end. Theclosed distal end does not permit any fluid flow therethrough and servesas a barrier between an interior of the housing 110 and an exteriorenvironment. The open proximal end of the housing 110 is configured toreceive at least a portion of a medical connector therein, as furtherdiscussed below with respect to FIGS. 12-14. The housing 110 can includea sidewall 112, which defines the open proximal end, and a base wall113, which defines at least a portion of the closed distal end.

The housing 110 can include a body region 136 near a proximal endthereof, which is substantially cylindrically shaped in the illustratedembodiment. A handle 137 can extend from the body region 136 so as to bepositioned at the distal end of the cap 102. The handle 137 can compriseany suitable gripping features 103, which, in the illustratedembodiment, comprise opposing gripping regions or grasping platforms 138that are configured to provide a convenient surface against which a usercan press so as to hold and/or twist the cap 102.

As shown in FIG. 4B, the illustrated grasping platforms 138 are mirroredabout a longitudinal plane LP that extends along a central longitudinalaxis A (shown in FIG. 4A) of the housing 110. Each grasping platform 138angles radially inwardly from the body region 136 toward thelongitudinal plane LP, in a proximal-to-distal direction. The graspingplatforms 138 are more steeply angled at their proximal ends than theyare at their distal ends. The angled platforms 138, and particularly thesteeply angled portions thereof, provide convenient surfaces to whichforces may be applied in a distal-to-proximal direction. In theillustrated embodiment, the platforms 138 define two substantiallyplanar regions that are smoothly joined to each other at a roundedtransition. The platforms 138 can define a contour that is substantiallycomplementary to fingertips that are pointed in the proximal direction.

As shown in FIG. 4A, the illustrated grasping platforms 138 also taperinwardly toward the central longitudinal axis A of the housing 110 in aproximal-to-distal direction. In the elevation view that is shown, theplatforms 138 are substantially ovoid. The platforms 138 are sized andshaped to be held between the fingertips of a thumb and another finger(e.g., the index finger) of a user, although other graspingconfigurations may also be efficiently employed with the illustratedarrangement. The platforms 138 provide convenient surfaces to whichtorque may be applied so as to rotate the cap 102 about the longitudinalaxis A.

With reference to FIGS. 4A-4C, the cap 102 can include a lip, rim, orflange 115 that extends radially inwardly at a proximal end of the bodyregion 136. The flange 115 can define one or more recesses 116, whichcan be complementary to features of the male cap 104 so as to define atleast a portion of a separation assisting cam, as discussed furtherbelow. The flange 115 also can contact an edge of the sleeve 191 portionof the male cap 104 to ensure the desired insertion depth of the cap 102within the sleeve 191.

With reference again to FIG. 4B, each recess 116 can be at leastpartially defined by a pair of faces 116 a, 116 b of the flange 115 thatare angled in opposite directions. The angles can be any suitablenon-zero, non-180-degree angles relative to a transverse cross-sectionalplane TP that passes perpendicularly through the a central axis A of thehousing 110. In particular, the faces 116 a can define an angle αrelative to the transverse plane TP, and the faces 116 b can define anangle β relative to the transverse plane TP. In the illustratedembodiment, the angles α, β are the same, although other arrangementsare possible (as discussed further below). For a path is traced alongthe flange 115 in a clockwise direction (when looking toward the flange115), the path moves proximally along the faces 116 a and the path movesdistally along the faces 116 b. The faces 116 a, 116 b can besubstantially planar over at least a portion thereof, and can beconfigured to complementarily contact faces of the sleeve 191.Additional discussion of the faces 116 a, 116 b is provided below withrespect to FIGS. 10A-10B.

The housing 110 defines an external surface 118 and an internal surface119, each of which extends away from the flange 115. The internalsurface 119 of the cap 102 can include an outwardly directed surface ofthe sidewall 112, a proximal end 124 of the sidewall 112, and aninwardly directed surface of the sidewall 112 (see FIGS. 4C and 9). Theoutwardly directed portion of the internal surface 119 can define aconnection interface 140 that is configured to interact with or engage aconnection interface 195 of the sleeve 191 (see FIG. 5C) so as toconnect the cap 102 to the sleeve 191. In the illustrated embodiment,the connection interfaces 140, 195 couple with each other via afriction-fit engagement. For example, an inner diameter of theconnection interface 195 of the sleeve 191 can be slightly smaller thanan outer diameter of the connection interface 140 of the cap 102. Thefriction fit can be sufficiently strong to provide a fluid-tight sealbetween the cap 102 and the sleeve 191, yet can allow the cap 102 to beremoved from the sleeve 191 via manipulation by a user (e.g., withoutthe use of ancillary tools). The fluid-tight seal can preventevaporative loss of antiseptic from an interior of the assembly 100 whenit is in the pre-use configuration and/or can maintain the sterility ofthe internal portions of the assembly 100. In other or furtherembodiments, the connection interfaces 140, 195 can include snap-fitdevices, threads, and/or any other suitable attachment features. In theillustrated embodiment, a proximal portion of the connection interface140 includes a chamfer 120, which can assist in centering the cap 102relative to the sleeve 191 when connecting the cap 102 to the sleeve191.

The proximal end 124 of the housing 110 (which is also a proximal end ofthe internal surface 119, or more generally, of the sidewall 112), candefine a seal inhibitor 125, which can include one or more contactregions 126 and one or more venting regions 127. In the illustratedembodiment, the seal inhibitor 125 includes two contact regions 126 thatare diametrically opposite from each other, and also includes twoventing regions 127 that are diametrically opposite from each other andare angularly spaced from the contact regions. Other configurations ofthe seal inhibitor 125 are also possible, such as, for example, the sealinhibitors discussed in U.S. patent application Ser. No. 12/610,141,titled STERILIZATION CAPS AND SYSTEMS AND ASSOCIATED METHODS, filed Oct.30, 2009, now published as U.S. Patent Application Publication No.2010/0049170, which was previously incorporated by reference in thisdisclosure. Operation of the seal inhibitor 125 is discussed furtherbelow with respect to FIG. 13.

With reference to FIGS. 4C and 9, the inwardly directed portion of theinternal surface 119 of the sidewall 112 can define a disinfectionchamber 122, which can include a connection interface 130. Any suitableconnection system may be used for the connection interface 130. In theillustrated embodiment, the connection interface includes threads 131.The connection interface 130 can be configured to attach the cap 102 toa medical connector in a secure yet selectively removable manner. Forexample, the cap 102 can be connected in any suitable manner with anysuitable medical connector. In other embodiments, the connectioninterface 130 may include latches or prongs that are configured to snapover an outwardly extending rib of a connector, or may include one ormore outwardly extending ribs over which one or more latches or prongsof the medical connector may snap. Other interfacing arrangements arealso possible, which may include friction-fit, snap-fit, or othersuitable mechanisms.

A proximal portion of the disinfection chamber 122 can be larger than adistal extension 123 of the chamber. In the illustrated embodiment, thedisinfection chamber 122 defines three substantially frustoconicalregions. The proximal region has a slightly tapered outer boundary thatdecreases in cross-sectional area in the distal direction; theintermediate region has a more pronounced tapered outer boundary thatmore rapidly decreases in cross-sectional area in the distal direction;and the distal region or distal extension 123 has a slightly taperedouter boundary that decreases in cross-sectional area in the distaldirection at about the same rate as the proximal region. Theintermediate and distal regions correspond with the proximal and distalregions, respectively, of the grasping platforms.

As can be appreciated from FIG. 9, the constricted intermediate regionof the disinfection chamber 122 can provide a reactive force to a distalend of the pad 132 when the cap 102 is secured to a medical connector.The reactive force can be sufficient to prevent the pad 132 from beingforced into the distal extension 123. In the illustrated embodiment, thethreads 131 also provide resistive forces. Axial compression of the pad132 as the cap 102 is coupled to a medical connector can swab theconnector and deliver antiseptic 133 from the pad 132 into contact withthe medical connector, as further discussed below. In some embodiments,the pad 132 may be resiliently deformable so as to regain a pre-useshape after a medical connector is decoupled from the cap 102. In otherembodiments, the pad 132 may instead be plastically deformable.

In various embodiments, the pad 132 can be configured to retain anantiseptic 133. For example, the pad 132 can comprise any suitablesponge-like material, such as an elastomeric foam, any open-cell foam,felt, or non-woven fiber matrix, and can be configured to conform to thecontours of a portion of a medical connector that is introduced into thedisinfection chamber 122 (e.g., uneven surfaces of an end of aneedleless injection site; see also FIGS. 12-14 and the associatedwritten description). The pad 132 can also comprise any closed-cellfoam, as well as a solid elastomeric material, such as silicone or thelike.

The pad 132 can have a series or network of openings or spaces thereinthat can retain the antiseptic 133 when the pad 132 is in an expandedstate. For example, the antiseptic 133 can be received within, occupy,fill (or partially fill), wet, soak, or saturate at least a fraction ofthe pad 132, or stated otherwise, can fill the pad 132 to a givenconcentration level. Compression of the pad 132 can cause antiseptic 133to egress from the pad 132 so as to contact the medical connector.Resilient expansion of the foam upon removal of a compressive force canallow the pad 132 to soak up or absorb at least some of the antiseptic133 that had previously been forced from the pad 132. In someembodiments, the antiseptic 133 can comprise any liquid antiseptic, suchas, for example, alcohol (e.g., isopropyl alcohol) at variousconcentrations (e.g., ranging from 50-90%), ethanol at variousconcentrations (e.g., ranging from 50-95%), and combinations of anyalcohols with any antiseptics, or a dry material, such as chlorhexidine,ethylenediaminetetraacetic acid (EDTA), lodaphors, or any suitablecombination thereof. Accordingly, although the antiseptic 133 isschematically depicted in FIG. 1 as a series of droplets, the antiseptic133 is not necessarily liquid and may fill the pad 132 to a greater orlesser extent than what is shown. In the illustrated embodiment, whenthe assembly 100 is in the pre-use condition, the pad 132 is in arelaxed, expanded, or uncompressed state in a longitudinal direction. Itis noted that the pad 132 may be uncompressed in one or more dimensions,yet compressed in one or more other dimensions, when the assembly 100 isin the pre-use state. For example, the pad 132 can be expanded or in arelaxed state in a longitudinal direction, yet compressed radiallyinwardly via the sidewall 112, when the assembly 100 is in the pre-usestate.

In the illustrated embodiment, the pad 132 is substantially square incross-section along its full longitudinal length when the pad 132 is ina relaxed orientation (see FIG. 3). Such an arrangement can facilitateand/or reduce material costs associated with the manufacture of the pad132. At least a portion of the pad 132 (e.g., the corners thereof) maybe compressed radially when the pad 132 is positioned within the housing112. Other rectangular cross-sections are also possible for the pad 132,and in other or further embodiments, the pad 132 may define arectangular cross-section along only a portion of the longitudinallength thereof. In other embodiments, at least a portion of the pad 132may define a round cross-section, such as a circular, elliptical, orother ovoid shape. For example, the pad 132 can be cylindrical so as tohave a circular cross-section. The pad 132 may define any other suitableshape, and may or may not be radially compressed when the assembly 100is in the pre-use state.

With reference to FIGS. 5A-5C, the housing 150 of the male cap 104 canextend between a closed distal end and an open proximal end. The closeddistal end does not permit any fluid flow therethrough and serves as abarrier between an interior of the housing 150 and an exteriorenvironment. The open proximal end of the housing 150 is configured toreceive at least a portion of a medical connector therein and/or topermit passage of at least a portion of the carriage 200 therethrough.

As viewed from the exterior (e.g., in FIGS. 5A and 5B), a shape and/orconfiguration of the distal end of the housing 150 can be similar oridentical to the distal end of the housing 110 of the female cap 102,which is discussed above. For example, in the illustrated embodiment,the housing 150 includes a body region 136 and a handle 137 withgrasping platforms 138, which when viewed exteriorly, are identical tothe identically numbered features of the cap 102. Accordingly, as can beseen in FIGS. 1 and 10A, when the assembly 100 is in the pre-use state,distal ends of an exterior thereof can be symmetrical about threemutually perpendicular planes. Other arrangements are also possible.

With continued reference to FIGS. 5A-5C, the housing 150 can include oneor more protrusions 197 that are configured to mate or cooperate withthe recesses 116 of the female cap 102. In particular, each pair ofcoupled protrusions 197 and recesses 116, or portions thereof, canoperate as a separation assist 107, as further discussed below withrespect to FIGS. 10A and 10B. The housing 150 can include a lip, rim, orflange 198 that extends radially inwardly at a proximal end of thesleeve 191. The housing 150 can define an external surface 165 and aninternal surface 166, each of which extends away from the flange 198.The internal surface 166 of the cap 104 can define the connectioninterface 195 discussed above.

The flange 198 can contact the flange 115 of the female cap 102, whichcan ensure the desired insertion depth of the cap 102 within the sleeve191. At least a portion of the flange 198 can be shaped complementarilyto the flange 115 of the cap 102. With reference to FIGS. 5A and 5B, theflange 198 can define a pair of faces 199 a, 199 b that are angled inopposite directions.

With reference to FIG. 5C, the housing 150 can define a receptacle orcavity 220 within which the carriage 200 may move between the retractedand extended positions. The housing 150 can further define one or moremovement constraining members 230, which may extend inwardly from (e.g.,project inwardly) or extend outwardly from (e.g., be recessed relativeto) the interior surface 166 of the housing 150. For example, thehousing 150 can include one or more, two or more, three or more, or fouror more movement constraining members 230. The illustrated embodimentincludes four movement constraining members 230 (only two of which areshown in FIG. 5C) that are angularly spaced from each other atapproximately 90 degree intervals. Other suitable arrangements are alsopossible.

In the illustrated embodiment, each constraining member 230 comprises aninwardly projecting track, protrusion, or spline 232. Each illustratedspline 232 includes a proximal stopping member or stop 233, which cancomprise a lock, latch, detent, or any other suitable stoppingmechanism. In the illustrated embodiment, each proximal stop 233 issubstantially wedge shaped and includes a distally angled entry face234, which can facilitate an overriding force or snap fit duringmanufacturing, and a transversely extending locking face 235. Thesplines 232 also can include transversely extending distal stoppingfaces 237, 238. In the illustrated embodiment, the splines 232 areelongated structures (e.g., ribs) that extend substantially parallel toeach other. In particular, the splines 232 are elongated in thelongitudinal direction, and each may be substantially parallel to alongitudinal axis defined by the housing 150. In some embodiments, thesplines 232 can have a helical configuration, which can resist distalmovement of the carriage 200 when the male cap 104 is coupled with amedical connector. Other suitable arrangements of the splines 232 arealso contemplated.

With reference to FIG. 6, the biasing member 202, which is a coil spring212 in the illustrated embodiment, can be received within the cavity220. A distal end of the coil spring 212 can contact the distal stoppingsurface 238, such that the distal stopping surface 238 can act as aresistive surface against which, or toward which, the coil spring 212can be compressed. In other embodiments, the biasing member 202 cancomprise any other suitable device that is configured to urge thecarriage 200 in the proximal direction. For example, the biasing member202 can comprise a resiliently deformable pad or support post of anysuitable material, such as those described elsewhere herein. In other orfurther embodiments, the biasing member 202 can comprise one or moresprings that are in forms other than helical, such as, for example,beam, leaf, conical, torsion, etc. Such springs may comprise anysuitable material, such as, for example, metals and/or polymers. In someembodiments, the biasing member 202 may be formed integrally with theouter housing 150 and/or the inner housing 210.

With reference to FIG. 7, the carriage 200 can be received within thecavity 220 and positioned at a proximal end of the spring 212. As shownin FIGS. 7 and 8, the inner housing 210 of the carriage 200 can comprisea body or base 250 that is sized and shaped to translate along alongitudinal path through the cavity 220. In the illustrated embodiment,the base 250 is substantially cylindrical. The base 250 can include aproximal extension 252, which may define a smaller outer diameter thanthe base 250. The illustrated proximal extension 252 is alsosubstantially cylindrical, and is coaxial with the base 250.

The inner housing 210 can include one or more movement constrainingmembers 253, which can be configured to cooperate with the movementconstraining members 230 of the outer housing 150 in order to constrain,guide, or otherwise control movement of the inner housing 210 within theouter housing 150. For example, the constraining members 253 of theinner housing 210 can be complementarily shaped relative to theconstraining member 230 of the outer housing 150. In the illustratedembodiment, each constraining member 253 of the inner housing 210comprises a groove or channel 254 that is sized to receive at least aportion of a spline 232. Accordingly, in the illustrated embodiment, theinner housing 210 comprises four channels 254 that are angularly spacedfrom each other by about 90 degrees.

The channels 254 can be configured to readily slide, glide, or otherwisetranslate over the splines 232. Each channel 254 can be defined bysidewalls 255, which may be substantially planar so as to smoothly passover substantially planar walls of the splines 232. Moreover, thesidewalls 255 may cooperate with the walls of the splines 232 to limit,inhibit, or prevent rotation of the inner housing 210 relative to theouter housing 150. Other suitable arrangements for the constrainingmembers 230, 253 are also possible. For example, in other embodiments,the constraining members 230 of the outer housing 150 may comprisechannels, whereas the constraining members 253 of the inner housing 210can comprise outwardly projecting splines that can translate within thechannels. In arrangements where the movement constraining members 230,253 are configured to prevent or inhibit rotation of the inner housing210 relative to the outer housing 150, the movement constraining members230, 253 may also be referred to as anti-rotation members.

As previously mentioned, in other embodiments, the splines 232 may besubstantially helical. The channels 254 and sidewalls 255 thus maylikewise define a substantially helical shape so as to appropriatelyinterface with the helical splines 232. In such an embodiment, themovement constraining members 230, 253 thus may permit rotationalmovement between the inner housing 210 and the outer housing 150,although the path of this rotational movement can be controlled by themovement constraining members 230, 253. Stated otherwise, the movementconstraining members 230, 253 can be configured to permit controlled,constrained, or limited rotational movement of the inner housing 210relative to the outer housing 150. A pitch of the helical constrainingmembers 230, 253 can be selected to achieve a desired operation of themale cap 104. For example, the pitch may be selected so as to allow thebiasing member 202 to move the carriage 200 proximally.

In the illustrated embodiment, each channel 254 includes a distalstopping member or stop 256, which can comprise a lock, latch, or anyother suitable stopping mechanism. In the illustrated embodiment, eachdistal stop 256 includes a substantially transversely extending facethat is configured to contact the transversely extending locking faces235 of the proximal stops 233. The distal stops 256 of the inner housing210 thus can cooperate with the proximal stops 233 of the outer housing150 to limit the translational movement of the inner housing 210. Inparticular, the stops 233, 256 can cooperate to prevent the innerhousing 150 from being pushed proximally out of the housing 150 by thecoil spring 212.

The base 250 of the inner housing 210 can include a distal surface 257.A distal projection 258 can extend distally from the surface 257. In theillustrated embodiment, the distal projection 258 is substantiallycylindrical and is sized to be received within the coil spring 212. Thedistal projection 258 can maintain the inner housing 210 in a centeredorientation relative to the spring 212.

In the illustrated embodiment, the base 250 of the inner housing 210includes a chamfer 260, which can assist in assembly of the male cap104. In particular, the chamfer 260 can aid in centering the innerhousing 210 relative to the outer housing 150 when the inner housing 210is inserted into the outer housing 150.

An open proximal end of the inner housing 210 can be sized and shaped toreceive at least a portion of a male protrusion of a medical connector.For example, the open proximal end of the housing 210 can be configuredto receive at least a portion of a male luer. The open end of thehousing 210 and the male luer can comply with ISO standards (e.g., ISO594-1:1986 and ISO 594-2:1998). Other arrangements are also possible.

The proximal extension 252 described above may also be referred to moregenerally as a male projection 241 portion of the inner housing 210. Theprojection 241 can be configured to couple with a medical connector thatincludes a male protrusion. The projection 241 includes a connectioninterface 242 that is configured to effect the coupling. In theillustrated embodiment, the projection 241 is substantially cylindrical,and the connection interface 242 comprises one or more threads 243 thatare positioned at an outwardly facing surface of the cylinder. Any othersuitable connection interface 242, such as any of those described above,is possible. As can be seen in FIGS. 7, 9, and 11A, the connectioninterface 242 can be at an interior of the outer housing 150 when theinner housing 210 is in the retracted position, and at least a portionof the connection interface 242 can be at an exterior of the outerhousing 150 when the inner housing 210 is in the extended position.

With reference to FIGS. 7 and 9, an inner surface 264 of the innerhousing 210 can define a disinfection chamber 268. As shown in FIG. 9, aproximal portion of the disinfection chamber 268 can include a proximalseal region 271, which can be configured to form a fluid-tight seal withthe male protrusion portion of a medical connector. For example, theseal region 271 may be shaped complementarily to an outer surface of amale protrusion of a medical connector with which the male cap 104 isconfigured to be used. In the illustrated embodiment, the proximal sealregion 271 comprises a substantially frustoconical surface 272 thatcomplies with ISO luer standards, as discussed above, such that aportion of a male luer can form a seal with the seal region 271. Thefrustoconical surface 272 can be tapered so as to decrease in diameterin a distal direction. In other embodiments, the proximal portion of thedisinfection chamber 268 may not be configured to form a fluid-tightseal with a male protrusion of a medical connector.

With continued reference to FIG. 9, the disinfection chamber 268 canfurther include an intermediate seal region 273. In the illustratedembodiment, the intermediate seal region is formed by a rim, ridge, lip,or shelf 274, which is defined by a short, substantially frustoconicalportion of the inner housing 210 that increases in diameter in thedistal direction. An outer edge of a proximal surface of the sealingmember 190 can define a greater outer diameter than a minimum innerdiameter of the shelf 274 such that the shelf 274 can maintain thesealing member 190 within the chamber 268. The shelf 274 also cancooperate with the sealing member 190 to seal the chamber 268 when theassembly 100 is in the pre-use state, as further discussed below.

A distal end of the resilient support 177, which may also be referred toas a post or a base element, can abut an inner surface of the distalprojection 258 of the inner housing 210. The resilient support 177 canbe configured to provide a base against which the antiseptic reservoiror pad 170 can be compressed so as to force antiseptic 133 therefrom.Accordingly, the resilient support 177 can be harder, stiffer, or lesscompliant than the pad 170, and can be configured to compress, under agiven force, to a smaller extent than the pad 170 does under the sameforce. For example, in various embodiments, the resilient support 177can be no less than about 2, 3, or 4 times harder than the pad 170.

The resilient support 177 can be elastically deformable such thatcompression of the support 177 from a relaxed orientation gives rise toa restorative force. The resilient support 177 can naturally return tothe relaxed orientation upon removal of the compressive force. Theresilient support 177 can comprise any suitable elastically deformablematerial. In some embodiments, the resilient support 177 comprises anelastomeric material, such as silicone. In certain embodiments, theresilient support 177 comprises a closed configuration (e.g., closedcell foam) or is otherwise nonabsorbent such that little or noantiseptic 133 that is expelled from the pad 170 is received into theresilient support 177. In other or further embodiments, the resilientsupport 177 may comprise a spring (e.g., a compression coil spring). Inother embodiments, such as mentioned elsewhere herein, a resilientsupport 177 is not used.

The pad 170 can comprise any suitable material, such as those describedabove with respect to other pads (including plastically deformablematerials, in some instances), and may be elastically or resilientlydeformable. In some embodiments, the pad 170 is attached to theresilient support 177 via any suitable adhesive or other attachmentmechanism, although in other embodiments, no such attachment mechanismsare used. For example, the pad 170 and the resilient support 177 may bemaintained in contact with each other due to a slight longitudinalcompression of one or more of these components once the cap 104 isassembled (e.g., once the support 177, the pad 170, and the sealingmember 190 are positioned between the support post 168 and the shelf174). Similarly, the pad 170 may be attached to the sealing member 190,or it may maintain a substantially fixed orientation relative to thesealing member 190 without such attachment due to the resilience of thepad 170 and/or the support 177, which are in a slightly compressedstate.

In the illustrated embodiment, the pad 170 is substantially square incross-section along its full longitudinal length when the pad 170 is ina relaxed orientation (see FIG. 3). Such an arrangement can facilitateand/or reduce material costs associated with the manufacture of the pad170. At least a portion of the pad 170 (e.g., the corners thereof) maybe compressed radially when the pad 170 is positioned within the innerhousing 210. Other rectangular cross-sections are also possible for thepad 170, and in other or further embodiments, the pad 170 may define arectangular cross-section along only a portion of the longitudinallength thereof. In other embodiments, at least a portion of the pad 170may define a round cross-section, such as a circular, elliptical, orother ovoid shape. For example, the pad 170 can be cylindrical so as tohave a circular cross-section. The pad 170 may define any other suitableshape, and may or may not be radially compressed when the assembly 100is in the pre-use state.

As previously mentioned, the pad 170 and the support 177 can, in someembodiments, cooperate as a two-part biasing member 176. It is to beunderstood that any other suitable biasing member 176 may be used, suchas those described above. The biasing member 176 can urge the sealingmember 190 in the proximal direction into sealing contact with the shelf274. The seal thus formed may be fluid-tight, and may prevent antiseptic133, whether in liquid or vapor form, from exiting the disinfectingchamber 268 prior to coupling of the male cap 104 to a medicalconnector. This proximal seal may be in place when the assembly 100 isin the pre-use configuration, as well as after the separation of themale and female caps 104, 102 when the assembly 100 is opened.

The illustrated sealing member 190 comprises unitary piece of materialthat includes a cylindrical region and a conical region. The conicalregion can be well-suited to form a seal with a tip of the projection ofa male medical connector. In some instances, an apex of the conicalregion can be received within a lumen 322 of a luer 320 when a medicalconnector is coupled with the cap 104 (see, e.g., FIG. 11A). The sealingmember 190 can be formed of any suitable material, such as, for example,an elastomer (e.g., silicone) or a thermoplastic, such as polypropylene,polycarbinate, acrylonitrile butadiene styrene (ABS), polyvinyl chloride(PVC), or rigid or semi-rigid thermoset plastic. The sealing member 190can be formed in any suitable fashion, such as via molding or diecutting. In some embodiments, the sealing member 190 can be harder, morerigid, and/or less compliant than the pad 170. The sealing member 190may be integral to the pad 170. For example, in some embodiments, thesealing member 190 may comprise a skin that is applied to the pad 170,or may comprise a modification of a surface of the pad 170 (e.g.,melting, heat forming, or the like). Other shapes of the sealing member190 are possible, including, for example, flat or planar, disk-shaped,spherical, etc.

When the assembly 100 is in the pre-use state shown in FIG. 9, the coilspring 212 can be in a compressed state such that a biasing force tendsto urge the carriage 200 in the proximal direction. This biasing forcecan be countered by interacting or cooperating surfaces of the innermale housing 210 and the female housing 110. In the illustratedembodiment, a proximal end or portion of the threads 243 of the innermale housing 210 and a proximal end or portion of the threads 131 of thefemale housing 110 contact each other and thereby cooperate to preventproximal movement of the carriage 200. In further embodiments, theproximal portions of the threads 131, 243 may engage one another. Forexample, the caps 102, 104 may be rotated relative to each other duringthe manufacture of the assembly 100 so as to cause the threads 131, 243to engage each other.

Other suitable arrangements or cooperating features may be used to urgethe carriage 200 into the retracted position and/or to retain thecarriage 200 in the retracted position. For example, in someembodiments, cooperating tabs or flanges that are separate from thethreads 131, 243 may be used.

The connection interface 195 of the male cap 104 and the connectioninterface 140 of the female cap 102 can cooperate with each other tomaintain the assembly 100 in the pre-use configuration. Any suitableconnection interfaces may be used for this purpose. In the illustratedembodiment, the connection interface 195 of the male cap 104 comprises aregion of the proximal end of the outer housing 150, and the connectioninterface 140 of the female cap 102 comprises a region of the proximalend of the housing 110. An inner surface of the proximal region of theouter housing 150 defines a similarly sized or smaller inner diameterthan does an outer surface of the proximal end of the housing 110 of thefemale cap 102, such that the proximal regions of the housings 150, 110can be tightly or securely fastened to each other in a friction fit. Thefriction fit can be sufficiently tight to resist biasing forces providedby the compressed spring 212 that would otherwise urge the carriage 210in a proximal direction and thereby urge the female cap 102 away fromthe male cap 104. The friction fit also can provide a fluid-tight sealthat can prevent antiseptic 133 from evaporating from an interior of theclosed assembly 100 to an exterior environment.

FIGS. 10A and 10B illustrate stages in a method of removing the femalecap 102 from the assembly 100. In some embodiments, it can beparticularly advantageous to use the separation assists 107 in theremoval process. For example, as just discussed, in some instances, thefriction-fit engagement and/or fluid-tight seal between the caps 102,104 can be relatively tight. Moreover, in some instances, a slightvacuum may be present within the assembly 100 and/or may arise withinthe assembly 100 as the cap 102 is removed from or separated from thecap 104. The separation assists 107 thus can advantageously facilitateremoval of the cap 102.

FIG. 10A illustrates the assembly 100 in the pre-use state, with thefaces 116 a, 199 a and 116 b, 199 b of the surfaces 115, 198 in contactwith each other. Each paired set of surfaces constitutes a separationassist 107. In the illustrated embodiment the assembly 100 includes fourseparation assists 107 rotationally spaced from each other at intervalsof approximately 90 degrees. Focusing now on an upper separation assist107 that includes the faces 116 a, 199 a, the face 116 a can define anangle α (see FIG. 4B) of about 20 degrees. The face 199 a of the sleeve191 is at the same angle, although oppositely directed.

In order to separate the cap 102 from the sleeve 191, the cap 102 can berotated relative the sleeve 191. In the illustrated embodiment, the cap102 is rotated clockwise, which can cause the faces 116 a, 199 a tointeract with each other and slide past each other. The cap 102 thuscams relative to the sleeve 191 as the rotational motion is convertedinto translational movement of the cap 102 away from the sleeve 191, asshown by the arrow in FIG. 10B.

Where the angles α, β (see FIG. 4B) of the surfaces 116 a, 116 b areidentical, the same mechanical advantage may be present whether the cap102 is rotated in the clockwise or counterclockwise directions. In otherembodiments, the separation assists 107 can be configured to aid inseparating the cap 102 from the sleeve 191 only when the cap 102 isrotated in one predetermined direction (e.g., either clockwise orcounterclockwise). For example, the pair of faces 116 a or the pair offaces 116 b may define an angle α or β, respectively, of 20 degrees soas to allow separation as shown in FIG. 10B, whereas the other pair offaces 116 a, 116 b may be at an angle of about 90 degrees (i.e.,approximately parallel to or extending through a central axis of the cap104) so as to prevent rotation and separation of the cap 104. Forexample, in some embodiments, the faces 116 a, 116 b may be configuredto allow the caps 102, 104 to be rotated only in a direction that woulddecouple threaded portions of the caps 102, 104, so as to therebyprevent initial or further coupling of the threaded portions of the caps102, 104 (which would tend to pull the caps 102, 104 into tighterengagement with each other, rather than allow them to separate from eachother). In other embodiments, one or more of the faces 116 a, 116 b maybe at larger or smaller angles α, β. For example, one or more of theangles α, β may be no more than about 15, 20, 1, 45, 60, or 75 degreesor no less than about 15, 20, 1, 45, 60, or 75 degrees. Otherconfigurations of the separation assists 107 are also possible. Forexample, in some embodiments, the complementary surfaces of the flanges115, 198 can define angles as just described, but the surfaces may berounded or otherwise non-planar.

Other arrangements of the separation assists 107 are contemplated. Forexample, in some embodiments, the female cap comprises one or moreprotrusions and the male cap comprises corresponding recesses. Infurther embodiments, the assembly 100 may be devoid of the separationassists 107. Moreover, in some instances, a user may be able to separatethe caps 102, 104 from each other by pulling primarily or solely in asubstantially longitudinal direction (e.g., without rotating the caps102, 104 relative to each other).

FIGS. 11A-11D illustrate consecutive stages of the male cap 104 beingcoupled with a medical device 300. In FIG. 11A, the male cap 104 hasbeen removed from the female cap 102. Separation of the female cap 102from the male cap 104 can reduce and eliminate opposition to the biasingforce of the spring 212, such that carriage 200 is urged from theretracted position shown in FIG. 9 to the extended position shown inFIG. 11A. When in the carriage is in the extended position, the maleprojection 241 can extend proximally beyond an edge of the outer housing150 so as to be more readily accessible by the device 300. The cap 104may be said to be in a connection-ready or accessible state when it isin an orientation such as that shown in FIG. 11A, as the inner housing210 is more readily accessible to the device 300 for connection theretothan it is when the male cap 104 is in the retracted orientation.

The proximal stops 233 of the outer housing 150 can cooperate with thedistal stops 256 of the inner housing 210, as discussed above. In someembodiments, once the proximal and distal stops 233, 256 have engagedeach other such that relative motion between the outer and innerhousings 150, 210 ceases, the spring 212 may continue to provide abiasing force to the inner housing 210. For example, the spring 212 mayremain somewhat compressed once the inner housing 210 has been extended.This residual biasing force can resist or oppose movement of thecarriage 200 back toward the retracted position when the medicalconnector 300 is moved distally relative to the cap 104 during coupling,as described below. In other or further embodiments, the sleeve 191and/or the carriage 200 may comprise a latch system or other suitablemechanism that can prevent distal movement of the carriage 200 relativeto the sleeve 191 once the carriage 200 has been moved proximally past apredetermined position. An illustrative example of such a latch systemis discussed below with respect to FIG. 17.

The medical device 300 includes a male protrusion 319, which in theillustrated embodiment is a male luer 320. As mentioned above, otherarrangements of the male protrusion 319 are also contemplated. A tip 321of the protrusion 319, can be received within the disinfection chamber268 prior to contacting the sealing member 190. Stated otherwise, thesealing member 190 can be recessed relative to a proximal end of theinner housing 210 by a distance that is sufficiently great to permit atleast a portion of the male luer 320 to be received within the innerhousing 210 before the male luer contacts the sealing member 190.

In the illustrated stage of the procedure, the luer 320 has beenadvanced sufficiently far into the disinfection chamber 268 to contactthe sealing member 190 and to form a seal therewith. The connectioninterface 242 of the inner housing 210 has not yet engaged a connectioninterface 312 of the medical connector 300 at this stage, and thesealing member 190 is just beginning to move distally within thedisinfection chamber 268 so as to break the proximal seal between thesealing member 190 and the shelf 274.

One or more portions of the biasing member 176 (i.e., one or more of theresilient support 177 and the pad 170) may provide a biasing force tothe sealing member 190 that is smaller than the biasing force that thespring 212 provides to the carriage 200. Accordingly, distal movement ofthe sealing member 190 may cause compression of one or more portions ofthe biasing member 176, so as to break the proximal seal between thesealing member 190 and the shelf 274, but may cause little or nocompression of the spring 212. The spring 212 thus may provide asuitable level of resistance to axial forces. In other or furtherembodiments, such as that described below with respect to FIG. 17, oneor more latches may be used, which can ultimately provide a resistiveforce that permits distal movement of the sealing member 190 uponinsertion of a portion of medial connector and/or that otherwiseprovides a suitable level of resistance to axial forces so as to permitdesired operation of the male cap 104.

In FIG. 11B, the luer 320 has been advanced slightly further into thedisinfection chamber 268, thereby compressing the pad 170 somewhat andforcing antiseptic 133 out of the pad 170. The sealing member 190 candefine an outer diameter than is smaller than an inner diameter of thisportion of the disinfection chamber 268 such that a fluid path ispresent about an exterior of the sealing member 190. Stated otherwise,the sealing member 190 has been urged distally to a position where aperiphery or outermost perimeter of the sealing member 190 is spacedfrom the an interior surface of the inner housing 210 such that anopening, spacing, or gap that exists between the sealing member 190 andthe interior surface of the inner housing 210. This opening may functionas a fluid port.

Antiseptic 133 thus can flow about the sealing member 190 and/or anyother portion of an open region that exists between the interior surfaceof the inner housing 210 and the outer surfaces of the resilient support177, the pad 170, the sealing member 190, and the luer 320. Furtheradvancement of the luer 320 into the disinfection chamber 268 can causethe antiseptic 133 to fill this open region. However, the antiseptic 133does not enter into the lumen 322 of the luer 320 due to the sealbetween the luer 320 and the sealing member 190. Further advancement ofthe luer 320 into the disinfection chamber 268 also can strengthen theseal between the luer 320 and the sealing member 190 due to theincreasing restorative forces that arise as the pad 170 is compressed.

As the pad 170 is softer or more compliant than the resilient support177, the pad 170 has been compressed to a much greater extent than theresilient support 177 at this stage. Indeed, in some embodiments, theresilient support 177 may compress only slightly or not at all at thisstage.

In the illustrated embodiment, the interfaces 242, 312 have just beguncoupling with each other at the stage shown in FIG. 11B. The threadedinterfaces 242, 312 are configured to be rotated relative to each otherfor purposes of engagement and disengagement. As previously discussed,the movement constraining members 230, 253 can cooperate with each otherto limit or prevent rotation of the inner housing 210 relative to theouter housing 150, which thus can facilitate coupling and/or decouplingof the medical connector 300 to/from the male cap 104. For example,rotation of the housing 150 can directly impart or transmit torque tothe inner housing 210 due to the movement constraining members 230, 253,which can provide a natural feel to a user. The handle 137 portionand/or the sleeve 191 portion of the male cap 104 thus can readily serveas a grip for rotationally coupling the male cap 104 to a medicalconnector. Moreover, in certain embodiments, upon engagement of thethreaded interfaces 242, 312 with each other, rotational motion of themedical connector 300 relative to the male cap 104 can draw the luer 320into the disinfection chamber 268 without giving rise to any orsignificant longitudinally directed forces that would tend to urge thecarriage 200 distally toward the retracted position. The handle 137portion of the male cap 104 can conveniently be used for imparting oropposing rotational movement relative to the medical connector 300.

In FIG. 11C, the luer 320 has been advanced even further into thedisinfection chamber 268, thereby compressing the pad 170 to a greaterextent and forcing additional antiseptic 133 into the interior regionsof the disinfection chamber 268. In the illustrated embodiment, theresilient support 177 is shown as having been slightly compressedrelative to its configuration in the stage shown in FIG. 66C, whereasthe pad 170 has been nearly completely compressed, such that all ornearly all of the antiseptic 133 has been forced therefrom. Cooperationbetween the connection interfaces 142, 312 can facilitate compression ofthe pad 170 and/or the resilient support 177.

Although the outer surface of the luer 320 appears to be nearly parallelto and in contact with the luer-tapered surface 272 of the interiorsurface of the inner housing 210, a fluid-tight seal may not have formedyet in this area. Accordingly, the antiseptic 133 may be permitted tocover the portion of the luer 320 that is within the chamber 268, whilein some embodiments, a small portion of antiseptic 133 may also bepermitted to exit from the disinfection chamber 268. The portion of theluer 320 that is within the disinfection chamber 268 thus may contactthe antiseptic 133 so as to be disinfected thereby.

FIG. 11D illustrates a final or fully coupled stage, or an end-of-strokeorientation, in which the luer 320 has been advanced even further intothe disinfection chamber 268 such that the luer 320 forms a seal withthe luer-tapered surface 272 of the inner housing 210. Antiseptic 133can be retained in all open portions of the disinfection chamber 268that are between the seal formed by the luer 320 and the sealing member190 and the seal formed by the luer 320 and the inner housing 210. Inthe illustrated embodiment, a relatively large portion of the luer 320,which includes all or most of the tip 321, is in continual contact withthe portion of the antiseptic 133 thus retained. This portion of theluer 320 can be bathed by the antiseptic 133 and disinfected thereby. Inother embodiments, larger portions of the luer 320 can be bathed.

The deformable nature of the resilient support 177 can allow for distalmovement of the pad 170, even after the pad 170 has been fullycompressed. Such an arrangement can allow for a range of acceptablelengths and diameters for the luer 320. For example, shorter luers 320than that illustrated in the drawings may still be able to fullycompress the pad 170 so as to expel all antiseptic therefrom.

In other embodiments, the medical connector 300 may include a maleprotrusion other than a luer 320, such as a male protrusion that isshaped substantially as a cylinder or in some other configuration, suchas a taper having dimensions other than those used for luer systems. Insome embodiments, the surface 272 may be shaped complementarily to theouter surface of such protrusions so as to for a seal therewith. Instill other embodiments, the inner housing 210 may not form a seal withthe protrusion.

When the luer 320 is removed from the chamber 268, the restorationforces of the pad 170 and/or the resilient support 177 (i.e., thebiasing member 176) can maintain the seal between the luer 320 and thesealing member 190, which can prevent antiseptic from entering into thelumen 322 of the luer 320.

Each of FIGS. 12-14 illustrates the female cap 102 coupled with aseparate needleless injection site 340, 360, 380. The cap 102 can beversatile so as to couple with a variety of different types of medicalconnectors in a secure fashion that disinfects each type of medicalconnector. As can be seen in each of FIGS. 12-14, coupling of theneedleless injection sites 340, 360, 380 with the cap 102 can effectcompression of one end of the pad 132. This compression, along withrotation of the needleless injection site 340, 360, 380 can effectrubbing, swabbing, or scrubbing of the needleless injection site anddisinfection thereof via the antiseptic 133.

With reference to FIG. 12, the needleless injection site 340 cancomprise a Clave® port available from ICU Medical, Inc. The needlelessinjection site 340 can include a housing 342 that defines a connectioninterface 344. The needleless injection site 340 can further include anelastomeric seal 346, which is shown in a closed configuration in whichfluid access is not permitted into a fluid passageway 348. Smallcrevices can exist between the housing 342 and the elastomeric seal 346at an end of the needleless injection site 340 that is inserted intodisinfection chamber 1922. As the connection interface 344 cooperateswith the connection interface 1930 defined by the sidewall 112 to drawthe tip of the needleless injection site 340 into the disinfectionchamber 122, the pad 132 can be compressed so as to generally conform tothe crevices. Compression of the pad 132 likewise can expel antiseptic133, which, in some instances, can fill in portions of the crevices thatthe pad 132 may not be able to contact directly. As the pad 132 iscompressed, the seal 346 can remain closed so as to prevent antiseptic133 from entering the fluid passageway 348.

With reference to FIG. 13, the needleless injection site 360 cancomprise a Q-Syte® port available from Becton, Dickinson and Company.The needleless injection site 360 can include a housing 362 and anelastomeric seal 366, which is shown in a closed configuration in whichfluid access is not permitted into a fluid passageway 368. As with theneedleless injection site 340, small crevices can exist between thehousing 362 and the elastomeric seal 366. However, the crevices canexist at a side portion of the needleless injection site 360, ratherthan at its tip. Nevertheless, as the needleless injection site 360 isadvanced into the cap 102, the pad 132 can be compressed so as togenerally conform to these differently shaped crevices. Compression ofthe pad 132 likewise can expel antiseptic 133, which, in some instances,can fill in portions of the crevices that the pad 132 may not be able tocontact directly. The seal 366 can be maintained in the closed positionduring the coupling procedure, so as to prevent any of the antiseptic133 from entering the fluid passageway 368.

With reference to FIG. 14, the needleless injection site 380 cancomprise a SmartSite® port available from Cardinal Health, Inc. Theneedleless injection site 380 can include a housing 382 and anelastomeric seal 386, which is shown in a closed configuration in whichfluid access is not permitted into a fluid passageway 388. As with theneedleless injection sites 340, 360, small crevices can exist betweenthe housing 382 and the elastomeric seal 386. However, these crevicescan be in yet different positions than those of the needleless injectionsites 340, 360. Nevertheless, as the needleless injection site 380 isadvanced into the cap 1102, the pad 132 can be compressed so as togenerally conform to these differently shaped crevices. Compression ofthe pad 132 likewise can expel antiseptic 133.

Each of the needleless injection sites 340, 360, 380 may advance intothe cap 102 by different amounts. The cap 102 thus can be adaptable andversatile. Additional, non-limiting examples of needleless injectionsites with which the cap 102 can selectively couple include theClearlink® Site available from Baxter and the InVision-Plus® availablefrom Rymed.

As shown in FIG. 13, in some arrangements, a portion of the sealinhibitor 125 can contact an outwardly projecting surface 369 of aneedleless injection site 360. In particular, the proximal end 124 ofthe cap 102 can contact the surface 369 at two separate contact regions126 when the cap 102 is fully coupled with the needleless injection site360. In the venting regions 127 (not shown in FIG. 13, see FIGS. 4A and4B), the proximal end 124 of the cap 102 can be spaced from the surface369. Such an arrangement can allow venting of antiseptic from thedisinfecting chamber 122 through the venting regions 127 into thesurrounding environment.

FIGS. 15 and 16 illustrate another embodiment of an assembly 400 thatincludes an embodiment of a female cap 402 and an embodiment of a malecap 404, which can resemble the assembly 100 and caps 102, 104 describedabove in certain respects. Accordingly, like features are designatedwith like reference numerals, with the leading digits “1” incremented to“4,” and the leading digit “2” incremented to “5.” Relevant disclosureset forth above regarding similarly identified features thus may not berepeated hereafter. Moreover, specific features of the assembly 400 maynot be shown or identified by a reference numeral in the drawings orspecifically discussed in the written description that follows. However,such features may clearly be the same, or substantially the same, asfeatures depicted in other embodiments and/or described with respect tosuch embodiments. Accordingly, the relevant descriptions of suchfeatures apply equally to the features of the assembly 400. Any suitablecombination of the features and variations of the same described withrespect to the assembly 100 can be employed with the assembly 400, andvice versa. Such disclosure methods apply to additional embodimentsdisclosed hereafter, such as those shown in each of FIGS. 17, 18, 19,and 20.

The female cap 402 includes a housing 410 that contains a pad 432. Thehousing 410 includes a sidewall 412 that defines a connection interface440. The male cap 404 includes an outer housing 450 that includes atelescoping carriage 500 therein. The outer housing 450 includes asleeve 491 that defines a connection interface 495. The connectioninterface 495 of the sleeve 491 is configured to cooperate with theconnection interface 440 of the sidewall 412 to couple the male cap 404to the female cap 402 so as to maintain the assembly 400 in the pre-useconfiguration. The coupled connection interfaces 440, 495 may form afluid-tight seal, such as described above.

In the illustrated embodiment, the connection interfaces 495 comprisesan annular projection 496 that extends radially inwardly, and theconnection interfaces 440 comprise a complementary annular recess 441that also extends radially inwardly. Each of the projection 496 and therecess 441 can extend about at least a portion of the respective caps402, 404 and can function as a snap-fit connection interface. In otherembodiments, the connection interface 495 may instead comprise a recessand the connection interface 440 may instead comprise a complementaryprojection. Other suitable connection interfaces are also contemplated.

An inner housing 510 of the carriage 500 can be somewhat shorter thanthe inner housing 210 described above. For example, the inner housing510 may be devoid of a distal extension portion (such as the distalextension 258). Correspondingly, a disinfecting chamber 568 defined bythe inner housing 510 may be shorter than the disinfecting chamber 268.

A biasing member 476 may comprise only a single piece, which in theillustrated embodiment is a resilient pad 470 that comprises anantiseptic therein. A sealing member 490 can be attached to or otherwisepositioned at a proximal end of the pad 470, and may function in amanner similar to the sealing member 190 described above.

The outer housing 450 can include one or more movement constrainingmembers 530 that are configured to cooperate with one or more movementconstraining members 553 of the inner housing 510 in manners such asdescribed above. The movement constraining members 530 of the outerhousing 450 can comprise splines 532 that are similar to the splines 232describe above. However, in the illustrated embodiment, the splines 532do not include stops (such as the stops 232) at the proximal endsthereof. The movement constraining members 553 of the inner housing 510can comprise channels 554 that are defined by sidewalls 555. However,the movement channels 554 may not include stops (such as the stops 256)at the distal ends thereof. Accordingly, the movement constrainingmembers 530, 553 may be configured primarily to limit rotationalmovement of the inner housing 510 relative to the outer housing 450,without limiting longitudinal (e.g., translational) movement between theinner and outer housings 510, 450.

In some embodiments, movement of the carriage 510 in the longitudinaldirection may be controlled or limited by a biasing member 502. Forexample, the biasing member 502 can comprise a spring 512 that isattached to a distal end of the carriage 512. The compressed spring 512can move the carriage 500 from the retracted position shown in FIG. 15to an extended position (such as that shown in FIG. 11A). When thecarriage 500 is in the extended position, the spring 512 may be in anatural or uncompressed state, such that the spring 512 naturallymaintains the carriage 500 in the extended position. Any furtherproximal movement of the carriage 500 thus would give rise to arestorative or biasing force in the spring 512 that would tend to movethe carriage 500 back to the extended position, which corresponds withthe equilibrium position of the spring 512. In other or furtherembodiments, as discussed further below, one or more of the inner andouter housings 510, 450 can comprise latching or locking features thatsecure the carriage 500 in the extended position once it has been movedthereto.

Any suitable arrangement of antiseptic, pads, and/or sealing members maybe used within the disinfecting chamber 568. Examples of varioussuitable arrangements can be found in U.S. patent application Ser. No.12/917,336, titled DISINFECTING CAPS AND SYSTEMS AND ASSOCIATED METHODS,filed Nov. 1, 2010, the entire contents of which were previouslyincorporated by reference herein.

FIG. 17 illustrates an embodiment of an outer housing 650 that can beused in a male cap, which may be used with an assembly 600. The assembly600 can resemble any of the assemblies discussed above. The outerhousing 650 can particularly resemble the outer housing 150, and caninclude one or more movement constraining members 630 such as themovement constraining members 230 described above. For example, themovement constraining members 630 can include splines 632 that includeproximal stops 633, and the stops can be configured to prevent acarriage 200, 500 from being fully extracted or urged from the outerhousing 650.

The assembly 600 can further include an additional movement constrainingmember 631 that is configured to maintain a carriage 200, 500 in theextended position, or stated otherwise, that is configured to prevent acarriage 200, 500 from being moved distally past a predeterminedposition once the carriage 200, 500 has been moved from the retractedposition to the extended position. Any suitable locking, latching, orretaining system may be used for the movement constraining member 631.For example, in the illustrated embodiment, the outer housing 650includes resilient arms 680 that are configured to move into a recess681. Only one arm 680/recess 681 system is shown in FIG. 17, butadditional such systems may be distributed about the outer housing 650.The additional systems may be at the same longitudinal position, butangularly spaced about the housing 650. The resilient arms 680 naturallyangle inwardly toward an axial center of the outer housing 650 in aproximal direction. Movement of the carriage 200, 500 in a proximaldirection can urge the resilient arms radially outwardly into therecesses 681. Once the carriage 200, 500 has passed the resilient arms680, the arms 680 can return to their natural inwardly projectingorientation, and proximal surfaces of the arms can contact one or moredistal surfaces of the carriage 200, 500 (e.g., the distal surface 257shown in FIG. 8) so as to prevent the carriage 200, 500 from thereaftermoving distally within the outer housing 650.

The resilient arm 680/recess 681 pair may be referred to as a latchingsystem 682. Any suitable arrangement of the latching system iscontemplated, and the system may include detents or other lockingfeatures. In some embodiments, a biasing member 202 may include at leasta portion of the latching system 682. For example, in some embodiments,the biasing member 202 may include the resilient arm 680 or anothersuitable locking feature that is forced into the recess 681 once thebiasing member 202 has been moved proximally to a predeterminedposition.

In the illustrated embodiment, the movement constraining members 630,631 are separate from each other. In other embodiments, they may beintegral to each other. For example, in some embodiments, the resilientarm 680 may be incorporated into a spline 632. In other embodiments, thespline 632 may include an additional stop, similar to the stop 633. Theadditional stop may be at a longitudinal position similar to that of thearm 680 shown in FIG. 17. The stop may be configured to allow thecarriage 200, 500 to pass by it in the proximal direction so as to movefrom the retracted to the extended position, but may be configured toprevent the carriage 200, 500 from moving distally past the stopthereafter. The stop may comprise a detent or any other suitablemechanism.

FIG. 18 illustrates another embodiment of an assembly 700 that includesan embodiment of a female cap 702 and an embodiment of a male cap 704.The assembly 700 can particularly resemble the assembly 100, but can bedevoid of a biasing member. In the illustrated embodiment, a selectiveengagement is established between a carriage 800 and the female cap 702such that when the male and female caps 704, 702 are separated for use,the carriage 800 is drawn by this selective engagement from theretracted position to the extended position. Once the carriage 800 hasbeen drawn to the extended position, the selective engagement can bebroken.

In the illustrated embodiment, the selective engagement between thefemale cap 702 and the carriage 800 may comprise an interfacing orinterlocking of threads 731 of the female cap 702 and the threads 843 ofthe carriage 800. For example, rather than mere contact between proximalends of the threads 131, 243, such as shown in FIG. 9, so as to maintainthe carriage 200 in the retracted position, a larger portion of theproximal portions of the threads 731, 843 that are shown in FIG. 18 maybe engaged with each other so as to both maintain the carriage 800 inthe retracted position and draw the carriage 800 from the retracedposition when the female cap 702 is pulled away from an outer housing750 of the male cap 704. Once the female cap 704 has thus translated thecarriage 800 to the desired position, the female cap 702 may be rotatedrelative to the carriage 800 (and, due to motion constraining members830, 853, relative to the outer housing 750 as well) so as to disengagethe threading 731, 843 and fully separate the female cap 702 from themale cap 704.

In the illustrated embodiment, a proximal end of the carriage 800compresses a proximal end of a pad 732 that is within the female cap 702when the assembly 700 is in the pre-use state. In other embodiments, theproximal end of the carriage 800 may be spaced from the pad 732 when theassembly is in the pre-use state so as not to compress the pad 732.

In other or further embodiments, selective engagement between the femalecap 702 and the carriage 800 can be effected by snap fitting, frictionfitting, heat stake, and/or other suitable approaches. In someembodiments, the carriage 800 may be retained in the extended position,once it has been drawn thereto, by locks, detents, or other suitablefeatures, as described above with respect to FIG. 17. For example, insome embodiments, the carriage 800 and/or the outer housing 750 maycomprise a latch such that, once the carriage has been moved to theproximal position, the latch prevents distal motion of the carriagerelative to the outer housing 150.

FIG. 19 illustrates another embodiment of an assembly 900 that includesan embodiment of a female cap 902 and an embodiment of a male cap 904.As with the assembly 700, the assembly 900 can be devoid of a biasingmember that is configured to move a carriage 1000 from a retractedposition to an extended position. Unlike the assembly 700, the assembly900 may further be devoid of features that couple the female cap 902 tothe carriage 1000 so as to move the carriage 1000 from the retractedposition to the extended position. Coupling of a medical connector (suchas the connector 300 discussed above) to a connection interface 1042 ofthe carriage 1000 may draw the carriage 1000 from the retracted positionto the extended position.

For example, in some embodiments, a sleeve portion 991 of an outerhousing 950 of the male cap 904 can be sufficiently shallow to permit atleast a portion of the connection interface 312 of the connector 300(see FIG. 11A) to engage a proximal portion of the connection interface1042. Tightening of the connector 300 onto the carriage 1000, such asvia rotation of the connector 300 relative to the carriage 1000, candraw the carriage 1000 from the retracted position to the extendedposition. In particular, the carriage 1000 can translate relative to theouter housing as the threaded connection interface 312 is advanced ontothreads 1043 of the connection interface 1042. In some embodiments, aset of movement constraining members 1030, 1053 can prevent the carriage1000 from rotating relative to the outer housing 950 and can ensure thatthe only or primary relative movement between the outer housing 950 andthe carriage 1000 is translational in a longitudinal direction.

In some embodiments, a male cap can be packaged independently of anyfemale caps when in a pre-use state, such that it may not be part of anassembly. For example, as shown in FIG. 20, in some embodiments, aproximal end of a male cap 1104 may be substantially flat or planar(e.g., devoid of the protrusions 197), and a removable cover 1186 may besecured to an outer housing 1150 of the cap 1104 in any suitable manner,such as, for example, via an adhesive. Preferably, the cover 1186 can bereadily removed by a practitioner. The cover 1186 may include agraspable tab 1187 to aid in the removal thereof. The adhesive may besufficiently strong to maintain the cover hermetically sealed about theproximal end of the outer housing 1150, and the cover and adhesive maybe sufficiently strong to counter the biasing force of a biasing member(e.g., the biasing member 202) so as to maintain an inner housing in theretracted position. The removable cover 1186 can be formed of anysuitable material, such as, for example, an impervious pliable material(e.g., foil, plastic, metallized-surface mylar). Examples of suitablecovers are illustrated in U.S. patent application Ser. No. 12/917,336,titled DISINFECTING CAPS AND SYSTEMS AND ASSOCIATED METHODS, filed Nov.1, 2010.

In some embodiments, the female caps 102, 402, 702, 902, which can beconfigured for use with medical connectors, may be replaced with capshaving a sole or primary purpose of covering the male caps 104, 404,704, 904 prior to use so as to maintain the sterility of the male caps,so as to prevent evaporative loss from the male caps, and/or so as tomaintain the carriage portions of the male caps in the retractedposition. Additionally, as previously discussed with respect to theassembly 100, in some embodiments, cooperation between the sealingmember 190 and the inner housing 210 can form a seal that is sufficientto prevent evaporative loss from the male cap 104.

The caps described herein, and components thereof, can be formed of, orcoated with various colored materials or coatings. In some embodiments,the caps each include the same color. In other embodiments, the capsinclude different colors. Coloring the caps can, in some instances,provide advantages, such as ready identification of the type of cap,ready matching of a particularly colored cap with a particular type ofmedical connector, and the like.

The foregoing disclosure recites various embodiments that include capsthat are configured to disinfect medical connectors. Certain of suchcaps can include an outer housing and an inner housing disposed withinthe outer housing. Illustrative examples of means for transitioning theinner housing from a retracted position to an extended position relativeto the outer housing include the biasing members 202, 502, the threading731, 843, and the connection interface 1042. Illustrative examples ofmeans for constraining movement of the inner housing relative to theouter housing include the movement constraining members 230, 253, 530,553, 630, 631, 830, 853, 1030, 1053.

It will be understood by those having skill in the art that many changesmay be made to the details of the above-described embodiments withoutdeparting from the underlying principles presented herein. For example,any suitable combination of features of the various embodiments ofassemblies described above is contemplated.

Any methods disclosed herein comprise one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.

It should be appreciated that in the above description of embodiments,various features are sometimes grouped together in a single embodiment,figure, or description thereof for the purpose of streamlining thedisclosure. This method of disclosure, however, is not to be interpretedas reflecting an intention that any claim require more features thanthose expressly recited in that claim. Rather, as the following claimsreflect, inventive aspects lie in a combination of fewer than allfeatures of any single foregoing disclosed embodiment. Thus, the claimsfollowing this Detailed Description are hereby expressly incorporatedinto this Detailed Description, with each claim standing on its own as aseparate embodiment. This disclosure includes all permutations of theindependent claims with their dependent claims.

References to approximations are made throughout this specification,such as by use of the terms “about” or “approximately.” For each suchreference, it is to be understood that, in some embodiments, the value,feature, or characteristic may be specified without approximation. Forexample, where qualifiers such as “about,” “substantially,” and“generally” are used, these terms include within their scope thequalified words in the absence of their qualifiers. For example, wherethe term “substantially planar” is recited with respect to a feature, itis understood that in further embodiments, the feature can have aprecisely planar orientation.

Recitation in the claims of the term “first” with respect to a featureor element does not necessarily imply the existence of a second oradditional such feature or element. Elements recited inmeans-plus-function format are intended to be construed in accordancewith 35 U.S.C. §112 ¶ 6. It will be apparent to those having skill inthe art that changes may be made to the details of the above-describedembodiments without departing from the underlying principles of theinvention.

We claim:
 1. A cap configured to disinfect a medical connector, the capcomprising: an outer housing that defines a proximal end, a distal end,and a cavity that opens to the proximal end and that extends from theproximal end toward the distal end; an inner housing disposed within theouter housing, the inner housing comprising a connection interface thatis configured to connect the inner housing to a medical connector, theinner housing having only a single opening, the opening directed onlytowards a proximal end of the inner housing, and the inner housingdefining a chamber having an antiseptic prior to use of the cap todisinfect the medical connector; and a biasing member that is coupledwith each of the outer and inner housings, the biasing member beinglocated within the outer housing but outside of the inner housing,wherein the biasing member is configured to bias the inner housingtoward an extended position; wherein the cap is configured to transitionfrom an unconnected state with the medical connector, in which the innerhousing is in a retracted position relative to the outer housing, to aconnected state with the medical connector, in which the inner housingis in the extended position relative to the outer housing, wherein theretracted position of the inner housing is closer to the distal end ofthe outer housing than is the extended position.
 2. The cap of claim 1,wherein the proximal end of the outer housing defines a connectioninterface that is configured to couple with a second cap so as to form aclosed assembly.
 3. The cap of claim 2, wherein the connection interfaceis configured to form a fluid-tight seal with the second cap so as toprevent evaporative loss of the antiseptic from the assembly.
 4. The capof claim 2, wherein the connection interface of the inner housingcomprises threading.
 5. The cap of claim 4, wherein the connectioninterface defined by the proximal end of the outer housing is devoid ofthreading.
 6. The cap of claim 1, wherein the biasing member comprises acompression spring.
 7. The cap of claim 1, wherein the biasing member isconnected to the inner housing such that the biasing member isconfigured to inhibit the inner housing from being removed from theouter housing.
 8. The cap of claim 7, wherein the biasing member is in astate of equilibrium when the inner housing is in the extended position.9. The cap of claim 1, wherein a proximal end of the inner housing is atan interior of the cavity of the outer housing when the inner housing isin the retracted position, and wherein the proximal end of the innerhousing is at an exterior of the outer housing when the inner housing isin the extended position.
 10. The cap of claim 1, wherein the innerhousing comprises a proximal projection that defines at least a portionof the chamber, and wherein the connection interface of the innerhousing comprises threading disposed at an outwardly facing surface ofthe projection.
 11. The cap of claim 1, wherein the outer housingcomprises a first movement constraining member and the inner housingcomprises a second movement constraining member that is configured tocooperate with the first movement constraining member so as to limitrelative movement between the outer and inner housings.
 12. The cap ofclaim 11, wherein the first and second movement constraining members areconfigured to limit or prevent rotation between the outer and innerhousings.
 13. The cap of claim 11, wherein the first and second movementconstraining members are configured to prevent removal of the innerhousing from the outer housing.
 14. The cap of claim 11, wherein thefirst and second movement constraining members are configured to allow acontrolled rotation between the outer and inner housings.
 15. The cap ofclaim 11, wherein one of the first and second movement constrainingmembers comprises a spline and the other of the first and secondmovement constraining members comprises a channel that is sized andshaped to receive the spline therein.
 16. The cap of claim 15, whereineach of the spline and the channel are helical.
 17. The cap of claim 1,wherein the outer and inner housings comprise a pair of stoppingsurfaces that are configured to cooperate with each other to prevent theinner housing from being moved entirely out of the outer housing. 18.The cap of claim 1, further comprising a latching system that isconfigured to maintain the inner housing in the extended position.
 19. Acap configured to disinfect a medical connector, the cap comprising: anouter housing that defines a proximal end, a distal end, and a cavitythat opens to the proximal end and that extends from the proximal endtoward the distal end; an inner housing disposed within the outerhousing, the inner housing comprising a connection interface that isconfigured to connect the inner housing to a medical connector, theinner housing having only a single opening, the opening directed onlytowards a proximal end of the inner housing, and the inner housingdefining a chamber having an antiseptic prior to use of the cap todisinfect the medical connector; and means for transitioning the innerhousing from a retracted position relative to the outer housing, whereinthe cap is unconnected with the medical connector, to an extendedposition relative to the outer housing, wherein the cap is connectedwith the medical connector, wherein the retracted position of the innerhousing is closer to the distal end of the outer housing than is theextended position, the means being located within the outer housing butoutside of the inner housing.